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FDA 510(k)

autoSCORE

K-Number: K231068 · 2024-01-07

ApplicantHolberg Eeg AS
Decision Date2024-01-07
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

autoSCORE is a medical device manufactured by Holberg Eeg AS. It received FDA 510(k) clearance on 2024-01-07 under approval number K231068. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the autoSCORE?

autoSCORE is a medical device that received FDA 510(k) clearance on 2024-01-07. It is manufactured by Holberg Eeg AS. The 510(k) number is K231068.

When was autoSCORE approved by the FDA?

autoSCORE received FDA 510(k) clearance on 2024-01-07, under approval number K231068.

What company makes autoSCORE?

autoSCORE is manufactured by Holberg Eeg AS.

What is the FDA product code for autoSCORE?

The FDA product code for autoSCORE is OMB.

Other Devices by Holberg Eeg AS

K243743autoSCORE (V 2.0.0)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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